Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium
NCT ID: NCT06566469
Last Updated: 2025-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
340 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-02
Study Completion Date
2025-05-01
Brief Summary
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Emergence delirium is common in older patients after surgery and associated with worse perioperative outcomes, including increased postoperative delirium. Nasal administrations of both dexmedetomidine and esketamine are approved for medical purposes. Combination of low-dose dexmedetomidine and esketamine has shown some synergic effects in analgesia and anxiolysis. In a recent randomized trial, combined nasal administration of dexmedetomidine and esketamine was more effective in reducing pre-dental anxiety in pediatric patients. The investigators hypothesize that perioperative nasal administration of dexmedetomidine-esketamine combination can reduce the incidence of emergence delirium in older patients after surgery.
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Detailed Description
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Delirium is a common brain dysfunction syndrome in older patients after major surgery. Delirium that occurs after surgery includes emergence delirium and postoperative delirium. Emergence delirium occurred in 17.5% to 37.0% of patients following general anesthesia. The reported incidence of postoperative delirium ranged from 12.0% to 32.9% in older patients after noncardiac surgery. It is well known that the occurrence of postoperative delirium is associated with adverse outcomes. Recent studies found that emergence delirium is also associated with adverse perioperative outcomes, including increased postoperative delirium, more non-delirium complications, longer hospital stay, and higher healthcare costs.
Dexmedetomidine is a highly selective alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effects. Prophylactic administration of dexmedetomidine preoperatively or intraoperatively has also been shown to reduce the incidence of postoperative delirium. Dexmedetomidine via nasal administration is now widely used for pediatric preoperative sedation. Nasal administration of dexmedetomidine is also used in adults. In a retrospective study, postoperative nasal administration of dexmedetomidine (100 μg) to elderly orthopedic surgical patients improved analgesia and reduced symptoms of agitation. A recent study of patients undergoing gynecologic laparoscopic surgery, night-time dexmedetomidine (1.5 µg/kg) administration by nasal drops from preoperative day 1 to postoperative day 5 improved sleep quality and reduced the incidence of postoperative delirium.
Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Low-dose intravenous infusion of ketamine is recommended for postoperative analgesia. Esketamine is s-enantiomer of ketamine and twice as potent as ketamine in analgesic potency. Nasal administration of esketamine is approved by FDA for intractable depression in adults. A randomized trial showed that nasal application of esketamine was effective in relieving post-thoracic puncture pain in adult patients without significant adverse effects. And postoperative pain is a common risk factor of emergence delirium and postoperative delirium.
This randomized trial is designed to test the hypothesis that combined nasal administration of dexmedetomidine-esketamine combination may reduce the incidence of emergence delirium in older patients after surgery.
Dexmedetomidine is a highly selective alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effects. Prophylactic administration of dexmedetomidine preoperatively or intraoperatively has also been shown to reduce the incidence of postoperative delirium. Dexmedetomidine via nasal administration is now widely used for pediatric preoperative sedation. Nasal administration of dexmedetomidine is also used in adults. In a retrospective study, postoperative nasal administration of dexmedetomidine (100 μg) to elderly orthopedic surgical patients improved analgesia and reduced symptoms of agitation. A recent study of patients undergoing gynecologic laparoscopic surgery, night-time dexmedetomidine (1.5 µg/kg) administration by nasal drops from preoperative day 1 to postoperative day 5 improved sleep quality and reduced the incidence of postoperative delirium.
Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Low-dose intravenous infusion of ketamine is recommended for postoperative analgesia. Esketamine is s-enantiomer of ketamine and twice as potent as ketamine in analgesic potency. Nasal administration of esketamine is approved by FDA for intractable depression in adults. A randomized trial showed that nasal application of esketamine was effective in relieving post-thoracic puncture pain in adult patients without significant adverse effects. And postoperative pain is a common risk factor of emergence delirium and postoperative delirium.
This randomized trial is designed to test the hypothesis that combined nasal administration of dexmedetomidine-esketamine combination may reduce the incidence of emergence delirium in older patients after surgery.
Conditions
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Older Patients
Nasal Administration
Dexmedetomidine
Esketamine
General Anesthesia
Emergence Delirium
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Combined dexmedetomidine-esketamine
A mixture of dexmedetomidine 0.5 µg/kg and esketamine 0.2 mg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Group Type
EXPERIMENTAL
Dexmedetomidine
Intervention Type
DRUG
Dexmedetomidine 0.5 µg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Esketamine
Intervention Type
DRUG
Esketamine 0.2 mg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Normal saline
Placebo (normal saline) at the same volume is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Group Type
PLACEBO_COMPARATOR
Normal saline
Intervention Type
DRUG
Normal saline at the same volume is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Interventions
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Dexmedetomidine
Dexmedetomidine 0.5 µg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Intervention Type
DRUG
Esketamine
Esketamine 0.2 mg/kg is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Intervention Type
DRUG
Normal saline
Normal saline at the same volume is administered via nasal spray at 20:30 pm the day before surgery and at 07:30 am and 20:30 pm the day of surgery.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Aged ≥ 65 years;
2. Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;
3. Planned to stay in hospital for at least 1 day after surgery.
2. Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;
3. Planned to stay in hospital for at least 1 day after surgery.
Exclusion Criteria
1. Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause);
2. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
3. Inability to communicate due to coma, severe dementia, or language barrier before surgery;
4. Brain trauma or neurosurgery;
5. Use of sedatives or hypnotics at bedtime during the last month;
6. History of hyperthyroidism or pheochromocytoma;
7. Preoperative left ventricular ejection fraction \<30%, or sick sinus node syndrome, severe sinus bradycardia (heart rate \<50 beats per minute), or atrioventricular block of degree II or higher without pacemaker, or systolic blood pressure \<90 mmHg before enrollment;
8. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;
9. Planned admission to the intensive care unit after surgery;
10. Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.
2. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
3. Inability to communicate due to coma, severe dementia, or language barrier before surgery;
4. Brain trauma or neurosurgery;
5. Use of sedatives or hypnotics at bedtime during the last month;
6. History of hyperthyroidism or pheochromocytoma;
7. Preoperative left ventricular ejection fraction \<30%, or sick sinus node syndrome, severe sinus bradycardia (heart rate \<50 beats per minute), or atrioventricular block of degree II or higher without pacemaker, or systolic blood pressure \<90 mmHg before enrollment;
8. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;
9. Planned admission to the intensive care unit after surgery;
10. Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor and chairman, Department of Anesthesiology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Countries
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China
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-405
Identifier Type: -
Identifier Source: org_study_id
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